Our Quality Certifications
At WIS Biotech (Shandong Zhuozhicheng Biotech Co., Ltd.), quality assurance is the foundation of everything we manufacture. Our gluconate mineral salts and specialty ingredients are produced in facilities that meet the highest international standards — giving food manufacturers, supplement brands, and pharmaceutical companies the confidence to source from us.
Every batch we ship comes with a full documentation package including Certificate of Analysis (COA), Technical Data Sheet (TDS), Material Safety Data Sheet (MSDS), and heavy metals testing reports.
ISO 9001 — Quality Management System
Our manufacturing operations are certified under ISO 9001, the internationally recognized standard for quality management systems. This certification covers our entire production process — from raw material sourcing and incoming quality control through manufacturing, packaging, and final release testing. ISO 9001 ensures consistent product quality, traceability, and continuous improvement across all operations.
FSSC 22000 / ISO 22000 — Food Safety Management
WIS Biotech holds FSSC 22000 certification, which builds upon ISO 22000 and incorporates HACCP principles. This certification demonstrates that our food-grade gluconate products — including calcium gluconate, zinc gluconate, ferrous gluconate, potassium gluconate, magnesium gluconate, copper gluconate, and glucono-delta-lactone (GDL) — are manufactured under rigorous food safety controls. FSSC 22000 is recognized by the Global Food Safety Initiative (GFSI) and accepted by major retailers and food companies worldwide.
HACCP — Hazard Analysis and Critical Control Points
Our production facilities operate under a comprehensive HACCP plan that identifies, evaluates, and controls food safety hazards at every stage of production. This systematic approach to food safety is fundamental to our manufacturing process and ensures that our ingredients meet the strict safety requirements of food and supplement manufacturers globally.
Halal Certification
All gluconate mineral salts produced by WIS Biotech are Halal certified. Our Halal certification covers the complete product range and is recognized in key markets including the UAE, Saudi Arabia, Qatar, Indonesia, Malaysia, Pakistan, Bangladesh, and other Muslim-majority countries. This certification is essential for food manufacturers and supplement brands serving the rapidly growing global Halal market.
Kosher Certification
WIS Biotech’s gluconate products carry Kosher certification, making them suitable for use in Kosher food products and dietary supplements. This certification is particularly important for our customers in the United States, Israel, and European markets where Kosher compliance is a key purchasing requirement.
Regulatory Compliance
Beyond our third-party certifications, WIS Biotech maintains compliance with major international food and pharmaceutical regulations:
- FDA (United States) — Our food-grade products comply with FDA 21 CFR requirements for food additives and GRAS (Generally Recognized as Safe) substances.
- EU Regulations — Products meet European food additive standards and EFSA requirements, with proper E-number designations where applicable (e.g., GDL as E575, Sodium Gluconate as E576).
- FSSAI (India) — Products comply with Food Safety and Standards Authority of India regulations for food-grade mineral salts.
- Codex Alimentarius — Manufacturing and product specifications align with international Codex standards for food chemicals.
Documentation Available Upon Request
We provide complete documentation packages for all products to support your regulatory filings and quality audits:
- Certificate of Analysis (COA) — Batch-specific analytical results
- Technical Data Sheet (TDS) — Detailed product specifications
- Material Safety Data Sheet (MSDS/SDS) — Safety and handling information
- Heavy Metals Testing Report — Arsenic, lead, cadmium, mercury analysis
- Certification copies — ISO, FSSC 22000, Halal, Kosher certificates
- Country-specific compliance documents as needed
Request Certification Documents
Need copies of our certificates or product documentation for your quality team? Contact us and we will send the relevant documents within 24 hours. You can also visit our Downloads page for quick access to product specifications and data sheets.
Frequently Asked Questions
Are all WIS Biotech products Halal and Kosher certified?
Yes. All gluconate mineral salts and specialty ingredients manufactured by WIS Biotech hold both Halal and Kosher certifications. Copies of current certificates are available upon request.
Can you provide certificates for customs clearance and import registration?
Absolutely. We routinely provide complete documentation packages tailored to the regulatory requirements of your destination country, including certificates of origin, free sale certificates, and product registration support documents.
How often are your certifications renewed?
Our ISO and FSSC 22000 certifications undergo annual surveillance audits, with full recertification every three years. Halal and Kosher certifications are renewed annually. We ensure all certifications remain current and valid at all times.
Do you support factory audits by customers?
Yes. WIS Biotech welcomes customer audits and third-party inspections of our manufacturing facilities. We regularly host audit teams from international food companies and trading partners. Contact us to schedule a visit.
